Acquired Immunity Syndrome or AIDS appears to be a progressive disease, although the rate of transition from one phase to another can be variable. These phases have assigned classifications. Asymptomatic individuals infected by HIV exist, as judged by the presence of circulating antibodies against the virus (M. G. Sarngadharan et al, Science, volume 224, p. 506, 1984). If they have no other markers, they are WR1 stage patients, by the Walter Reed classification (R. R. Redfield et al, New England Journal of Medicine, volume 314, p. 131, 1986). They have been also called pre ARC (ARC=AIDS-related complex), although some of these individuals may never develop ARC symptomatology. Some of these patients may develop lymphadenopathy (WR2) and exhibit the T4 cell deficit (WR3). Next, the ability of lymphocytes to undergo antigen-stimulated proliferation and antigen-stimulated interferon-gamma production decreases and these WR4 patients begin to lose delayed cutaneous hypersensitivity. WR5 patients are usually anergic. They exhibit Herpes Zoster infections, oral candidiasis (thrush), or ARC symptoms which include prolonged fevers, night sweats, fatigue, diarrhea and/or weight loss. This period of ARC is usually also characterized by progressive immune decay. Finally, WR6 individuals experience opportunistic infections constituting "full-blown" AIDS, with 50% of the patients dyeing within 12 months (H. W. Murray et al, New England Journal of Medicine , volume 310, p. 883, 1984).
HIV infections follow a progression of symptoms and clinically measurable indicators. The infection typically progresses at a rate that is readily quantified by various available measurable disease parameters, explained in more detail below. This invention measures two or more of these parameters and correlates them with disease severity. Therapeutic intervention with dsRNAs stabilizes and reverses the otherwise inevitable downward trend of the infection.
In overall terms, there are two major stages of HIV infection --the first may be called non-life threatening and include, in order of progression: asymptomatic individuals who react positively to tests for HIV antibodies in the individuals blood or blood fraction, that is having circulating anti-HIV antibodies (the seropositive individuals); those individuals exhibiting lymphadenopathy syndrome (LAS) including symptoms of anergy or symptomless; pre-AIDS related complex (Pre ARC); and AIDS-related complex (ARC) including one or more symptoms of a generalized lymphadenopathy, fatigue, night sweats and anergy, among others. The second stage may be termed life-threatening and this is "full blown" or frank AIDS. These two major stages are depicted graphically in the attached drawing.